The multi-dimensional support of 'clinBEST database' facilitates the clinical development of anti-tumor new drugs

With the globalization of drug research and development, the demand of Chinese pharmaceutical enterprises for the clinical development of new drugs continues to rise. However, the clinical development of new drugs always requires very strong logic and design, as well as continuous acquisition of new information and adjustment of development strategies in the whole process. If a practical tool can help us obtain and sort out the clinical information of drugs, the clinical development of new drugs will become more efficient.

On December 10, 2022, Dr. Han Haixiong, chief medical officer of Shanghai Youlin Pharmaceutical Technology Co., LTD., delivered a report titled "The application of clinBEST in the Formulation of clinical research and development strategies for Oncology New Drugs" at the "2022 High Quality Development Conference of Major Health Industry and the Seventh China Pharmaceutical R&D and Innovation Summit". The report shared with us a practical tool for the formulation and adjustment of clinical oncology drug development strategies - clinBEST database.

In his early years at Institute of Biochemistry, Chinese Academy of Sciences, Dr. Han focused on the basic research of tumor etiology and the research and development of molecular discovery of anti-tumor drugs. Later, he turned to the clinical research and development of anti-tumor drugs. He has first-hand experience and profound understanding of the basic research and development of cancer and the whole chain of drug research and development. In the past 10 years, I have led and taken charge of more than 30 tumor new drug projects, covering the whole process of medical work from project initiation, R&D strategy formulation, IND report, trial implementation and research summary.

First, the decision of clinical development of anti-tumor drugs needs sufficient multidimensional data support

In recent years, domestic drug research and development enterprises are in a highly developed stage, but also need to participate in some international competition. For many enterprises, when developing new drug research and development strategies, they often need the support of a lot of data to determine the research and development strategy. The starting point and end point of all drug development are clinical, so drug clinical information data plays a pivotal role in the process of drug development.

In this report, Dr. Han Haixiong also first mentioned that the decision of clinical development of anti-tumor drugs needs sufficient multidimensional data support. The first step in clinical drug development decision-making is to obtain existing research data on a drug, such as its characteristics, advantages and risks. The second step is to investigate the whole field, including the competition pattern of drugs, the development path of similar products and the treatment status of indications. These two steps often require multi-dimensional data support, and also need to spend a lot of time on data research and retrieval, so they occupy a lot of work in the formulation of clinical development strategy. After these two steps, the preliminary development strategy can be formed, and then the final strategy can be determined after multi-party discussion. Dr. Han Haixiong concluded that "most decision-making problems are actually information problems". How to obtain more and more accurate information and then make a summary and judgment is a very important point in the development of new drug strategy at present, but also a certain challenge.

2. Data investigation and retrieval of pain points generated clinBEST database

Dr. Han Haixiong pointed out: At present, there are still some pain points in data research and retrieval. One is that the data sources are multiple and scattered, and the data quality varies. Another is that the terminology is not uniform, it is difficult to collect and compare horizontally.

Based on the above pain points, Shanghai Youlin Pharmaceutical Technology Co., Ltd. cooperated with Pharmacizhi.com to develop clinBEST database. Dr. Han Haixiong said: In order to ensure the accuracy and authenticity of the data source of the database, the data capture source is the official website of the national authority. At the same time, in order to avoid the problems of inconsistent terms or inconsistent data sources, association processing is carried out on the data with inconsistent terms, and structured analysis is carried out on the data from different sources, so as to make it more flexible and better meet the needs of users. Finally, I made a cloud deployment online. You only need to enter a website to enter the database interface.

Currently, the database presentation module consists of four parts: targets and drugs, clinical trials, marketing, and CSCO guidelines. Dr. Han Haixiong introduced in detail the relevant information each module can provide to users.

(1) Targets and drugs: Through the module of targets and drugs, we can know the type of a certain target, the abbreviation of the target, the corresponding drugs of the target, and what are the types of drugs? The corresponding indications of the drug, the highest research and development unit and the original research unit information.

(2) Clinical trials: Through this module, we can know the target and drug clinical trials, including registration number, clinical trial design, trial group, drug combination, its research and development stage, biomarkers and research and development units, etc.

(3) Marketing: This module can know the information of marketed drugs of a certain target, including drug name, biomarkers, the time and indication of the drug on the market in China, the United States and Europe.

(4) CSCO guidelines: Through this module, we can know information such as medication treatment measures, indication grades and recommended level evidence types for an indication in the CSCO guidelines.